Bioagent Export Control List

This list is subject to change (last updated November 2013).

Per the Export Administration Regulations (EAR; Category 1 – Materials, Chemicals, Microorganisms and Toxins, last updated 2013-10-15), a license will be required to export the following bioagents. Other export controls may apply for possession and use in the U.S.

For more information see the UF Office of Research web page on Export Controls.

Note: These ECCNs control all biological agents and toxins, regardless of quantity or attenuation, that are identified in the List of Items Controlled for the ECCN, including small quantities or attenuated strains of select biological agents and toxins that are excluded from the lists of select biological agents and toxins by APHIS, the CDC and HHS (7 CFR 331, 9 CFR 121, and 42 CFR 73).

While many of these items are select agents, those preceded by an asterisk(*) are not, but still require an export permit.

Human and Animal Pathogens (ECCN 1C351 & 1C352)

Viruses

    1. 1918 pandemic influenza virus – reconstructed replication competent forms containing any portion of the coding regions of all 8 gene segments.
    2. African horse sickness virus
    3. African swine fever virus
    4. *Andes virus
    5. Avian influenza (AI) viruses identified as having high pathogenicity (HP), as follows:
      1. AI viruses that have an intravenous pathogenicity index (IVPI) in 6-233k old chickens >1.2 or
      2. AI viruses that cause at least 75% mortality in 4- to 8-week old chickens infected IV.
        Note: Avian influenza viruses of the H5 or H7 subtype that do not have either of the characteristics described above should be sequenced to determine whether multiple basic amino acids are present at the cleavage site of the haemagglutinin molecule (HAO). If the amino acid motif is similar to that observed for other HPAI isolates, then the isolate being tested should be considered HPAI and the virus is controlled under 1C352.a.2.
    6. *Blue tongue virus
    7. Chapare virus
    8. *Chikungunya virus
    9. *Choclo virus
    10. Congo-Crimean haemorrhagic fever virus
    11. *Dengue fever virus
    12. *Dobrava-Belgrade virus
    13. Eastern equine encephalitis virus
    14. Ebola virus
    15. Foot and mouth disease virus
    16. Goat pox virus
    17. Guanarito virus
    18. *Hantaan virus
    19. Hendra virus (Equine morbillivirus)
    20. Hog cholera virus (Classical swine fever virus)
    21. *Japanese encephalitis virus
    22. Junin virus
    23. Kyasanur Forest virus
    24. *Laguna Negra virus
    25. Lassa fever virus
    26. *Louping ill virus
    27. Lujo virus
    28. Lumpy skin disease virus
    29. *Lymphocytic choriomeningitis virus
    30. *Lyssa virus (Rabies virus)
    31. Machupo virus
    32. Marburg virus
    33. Monkey pox virus
    34. *Murray Valley encephalitis virus
    35. Newcastle disease virus
    36. Nipah virus
    37. Omsk haemorrhagic fever virus
    38. *Oropouche virus
    39. Peste des petits ruminants virus
    40. Porcine enterovirus type 9 (swing vesicular disease virus)
    41. *Porcine herpes virus (Aujeszky’s disease, Pseudorabies virus)
    42. *Powassan virus
    43. Rift Valley fever virus
    44. Rinderpest virus
    45. *Rocio virus
    46. Sabia virus
    47. SARS-associated coronavirus (SARS-CoV)
    48. *Seoul virus
    49. Sheep pox virus
    50. *Sin Nombre virus
    51. *St. Louis encephalitis virus
    52. *Teschen disease virus
    53. Tickborne encephalitis virus (Far eastern subtype, formerly Russian Spring-Summer encephalitis virus)
    54. Tickborne encephalitis virus (Siberian subtype, formerly West Siberian virus)
    55. Variola virus
    56. Venezuelan equine encephalitis virus
    57. *Vesicular stomatitis virus
    58. *Western equine encephalitis virus
    59. *Yellow fever virus

Bacterial, Fungal and Rickettsial Agents

    1. Bacillus anthracis
    2. Brucella abortis
    3. Brucella melitensis
    4. Brucella suis
    5. Burkholderia mallei (Pseudomonas mallei)
    6. Burkholderia pseudomallei (Pseudomonas pseudomallei)
    7. *Chlamydophila psittaci (formerly Chlamydia psittaci)
    8. Clostridium argentinense (formerly Clostridium botulinum Type G), botulinum neurotoxin producing strains
    9. Clostridium baratii, botulinum neurotoxin producing strains
    10. Clostridium botulinum
    11. Clostridium butyricum, botulinum neurotoxin producing strains
    12. *Clostridium perfringens, epsilon toxin producing types
    13. *Coccidioides immitis
    14. *Coccidioides posadasii
    15. Coxiella burnetii
    16. Francisella tularensis
    17. Mycoplasma capricolum subspecies capripneumoniae (“strain F38”)
    18. Mycoplasma mycoides subspecies mycoides SC (small colony, contagious bone pleuropneumonia)
    19. Rickettsia prowazekii
    20. *Rickettsia rickettsia
    21. *Salmonella typhi
    22. *Shiga toxin producing Eschericia coli (STEC; a.k.a. enterohaemorrhagic E. coli (EHEC) or verocytotoxin-producing E. coli (VTEC)) of serogroups O26, O45, O103, O104, O111, O121, O145, O157 and other Shiga toxin producing serogroups
    23. *Shigella dysenteriae
    24. *Vibrio cholera
    25. Yersinia pestis

Biological Toxins and subunits thereof

    1. Abrin
    2. *Aflatoxins
    3. Botulinum toxins
    4. *Cholera toxin
    5. *Clostridium perfringens toxins
    6. Conotoxin
    7. Diacetosyscirpenol toxin
    8. *HT-2 toxin
    9. *Microcystin (Cyanginosin)
    10. *Modeccin toxin
    11. Ricin, Ticinus Agglutinin II (RCAII), ricin D, Ricinus Lectin III (RCLIII), Ricinus Lectin IV (RCLIV), ricin E
    12. Saxitoxin#
    13. *Shiga toxin
    14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly Staphylococcus enterotoxin F)
    15. T-2 toxin
    16. Tetrodotoxin
    17. *Verotoxin and other Shiga-like ribosome inactivating proteins
    18. *Viscum Ablum Lectin 1 (Viscumin)
    19. *Volkensin toxin

#While only saxitoxin is controlled on the CCL, other members of the paralytic shellfish poison family (e.g., neosaxitoxin) are designated EAR99 (see below).

Plant Pathogens (ECCN 1C354)

    1. *Andean potato latent virus (Potato Andean latent virus)
    2. *Clavibacter michiganensis subspecies sepedonicus (Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum)
    3. *Cochliobolus miyabeanus (Helminthosporium oryzae)
    4. *Colletotrichium kahawae (Colletotrichium coffeanum var. virulans)
    5. *Magnaporthe oryzae (Pyricularia oryzae)
    6. *Microcyclus ulei (Dothidella ulei)
    7. Peronosclerospora philippinensis (Peronosclerospora sachhari)
    8. Phoma glycinicola (formerly Pyrenochaeta glycines)
    9. *Potato spindle tuber viroid
    10. *Puccinia graminis ssp. Graminis var. graminis/Puccina graminis ssp. Graminis car. Stakmanii (Puccinia graminis [syn. Puccinia graminis f.sp. Tritici])
    11. *Puccinia striiformia (Puccinia glumarum)
    12. Ralstonia solanacearum, race 3, biovar 2 (Burkholderia solanacearum, race 3, biovar 2)
    13. Rathayibacter toxicus
    14. Sclerphthora rayssiae var. zeae
    15. Synchytrium endobioticum
    16. *Thecaphora solani
    17. *Tilletia indica
    18. *Xanthomonas albilineans
    19. *Xanthomonas axonopodis pv. Citri (Xanthomonas campestris pv. Citri A) (Xanthomonas campestris pv. Citri)
    20. Xanthomonas oryzae

Genetic Elements and genetically modified organisms (ECCN 1C353)

Genetic Elements

    1. Genetic elements that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a to .c, 1C352 and 1C353.
    2. Genetic elements that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “sub-units of toxins” thereof.

Genetically modified organisms

    1. Genetically modified organisms that contain nucleic acid sequences associated with the pathogenicity of microorganism controlled by 1C351.a to .c, 1C352 and 1C353.
    2. Genetically modified organisms that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “sub-units of toxins” thereof.

Technical Notes:

    1. “Genetic elements” include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified, or chemically synthesize in whole or in part.
    2. This ECCN does not control nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Eschericia coli, serotype O157 and other verotoxin producing strains, except those nucleic acids that contain coding for the verotoxin or its sub-units.
    3. “Nucleic acid sequences associated with the pathogenicity of any of the microorganisms controlled by 1C352.a to .c, 1C352, or 1C354” means any sequence specific to the relevant controlled microorganism that:
      1. In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
      2. Is known to enhance the ability of a microorganism controlled by 1C352.a to .c, 1C352, or 1C354, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to human, animal or plant health.
    4. “Genetically modified organisms” include organisms in which the genetic material (nucleic acid sequences) has been altered in a way that does not occur naturally by mating and/or natural recombination, and encompasses those produced artificially in whole or in part.

EAR99

As a result of recent changes to the CDC/APHIS list of Select Agents and Toxins, the following select agents that were formerly controlled by ECCN 1C360 are no longer listed on the CCL and are now classified as EAR99 instead:

    1. Central European Tickborne encephalitis viruses:
      1. Absettarov virus
      2. Hanzalova virus
      3. Hypr virus
      4. Kumlinge virus
    2. Cercopithecine herpesvirus 1 (Herpes B virus)
    3. Flexal virus
    4. Akabane virus
    5. Bovine spongiform encephalopathy agent
    6. Camel pox virus
    7. Malignant catarrhal fever virus
    8. Menangle virus
    9. Erhlichia ruminantium (a.k.a. Cowdria rumunantium)
    10. Xylella fastidiosa pv. citrus variegated chlorosis (CVC)

Items designated as EAR99 may be exported using the license exception NLR, specifying no license requires, as long ALL of the following criteria are met:

    1. The item is not being shipped to a sanctioned destination;
    2. The item is not being shipped to a denied person, sanctioned entity or prohibited end-user; and
    3. The item will not be used for a specific end-use, subject to higher controls.

International Traffic in Arms Regulations (ITAR)

Category XIV: Toxicological Agents including Chemical, Biological Agents, and Associated Equipment

MULTIPLE Export Controls, INCLUDING a License will be required to use or possess the following:

(b) Biological agents and biologically derived substances specifically developed, configured, adapted, or modified for the purpose of increasing their capability to produce casualties in humans or livestock, degrade equipment or damage crops.

(f) Equipment and its components, parts, accessories, and attachments specifically designed or modified for military operations and compatibility with military equipment as follows:

    1. The dissemination, dispersion or testing of the biological agents listed in paragraph (b);
    2. The detection, identification, warning or monitoring of the biological agents listed in paragraph (b);
    3. Sample collection and processing of the biological agents listed in paragraph (b);
    4. Individual protection against the biological agents listed in paragraph (b);
    5. Collective protection against the biological agents listed in paragraph (b);
    6. Decontamination or remediation of the biological agents listed in paragraph (b).

Additional items associated with, or specific to, the biological agents listed in paragraph (b) are also controlled under the ITAR including medical countermeasures (pre- and post-treatments, vaccines, antidotes, medical diagnostics); modeling or simulation tools; equipment, components, parts, accessories and attachments, exclusive of incinerators specifically designed/modified for the destruction of biological agents in paragraph (b); technical data and defense services. For more information on these items please refer to Category XIV – Toxicological Agents, including Chemical Agents, Biological Agents and Associated Equipment sections (g) through (m), page 486.